WO2013094644A1 - 皮下埋め込み型薬液注入具 - Google Patents
皮下埋め込み型薬液注入具 Download PDFInfo
- Publication number
- WO2013094644A1 WO2013094644A1 PCT/JP2012/082949 JP2012082949W WO2013094644A1 WO 2013094644 A1 WO2013094644 A1 WO 2013094644A1 JP 2012082949 W JP2012082949 W JP 2012082949W WO 2013094644 A1 WO2013094644 A1 WO 2013094644A1
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- WO
- WIPO (PCT)
- Prior art keywords
- annular
- seal member
- drug solution
- bottom member
- implantable drug
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
- A61M2039/0072—Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0229—Subcutaneous access sites for injecting or removing fluids having means for facilitating assembling, e.g. snap-fit housing or modular design
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0238—Subcutaneous access sites for injecting or removing fluids having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
Definitions
- the present invention relates to a drug solution injector for injecting a drug solution into a patient's body, and more particularly to a subcutaneously implantable drug solution injector used for treatment such as chemotherapy.
- a chemical solution injection therapy in which a chemical solution is injected into the body is performed.
- a subcutaneous implantable drug injector is used.
- the chemical solution injector include, for example, Patent Document 1 (Japanese Patent Publication No. 4-10832, USP 4,929,236), Patent Document 2 (WO 2009/35582), and Patent Document 3 (Patent Document 3) proposed by the applicant of the present application. No. 2004-350937).
- These chemical solution injectors include a main body composed of a ring-shaped upper member and a bottom member, and a seal member (septum) housed in the main body in a state where the peripheral edge is pressed between the upper member and the lower member.
- An inner space for injecting medicine is formed by the lower surface of the seal member (septum) and the inner surface of the main body, and the main body is provided with a flow path for outflow of the chemical liquid communicating with this space.
- the seal member (septum) is a rubber stopper and can be punctured a plurality of times with a drug injection needle.
- the seal member (septum) is in a state where the peripheral edge is pressed and sandwiched between the upper member and the bottom member forming the main body. At the same time, the lower part of the septum penetrates into the bottom member.
- the seal member (septum) is deformed by pressing the peripheral edge between the upper member and the bottom member, and due to this deformation, a gap is formed between the inner surface of the bottom member and the lower peripheral edge of the seal member (septum). It was difficult to avoid the formation. And the blood component which penetrate
- the object of the present invention is to provide a thrombus or the like caused by blood intrusion into the gap between the inner surface of the bottom member that houses the lower part of the seal member (septum) and the lower peripheral edge of the seal member (septum).
- the present invention provides a subcutaneously implantable drug solution injector (access port) capable of preventing the occurrence.
- An injection tool main body comprising a ring-shaped upper member and a bottom member closing the bottom surface of the upper member; and being accommodated between the upper member and the bottom member, closing an opening of the upper member; and the injection tool
- a subcutaneously implantable chemical solution injector comprising a seal member that forms a chemical solution inflow space in the body and a discharge port that communicates with the chemical solution inflow space, wherein the bottom member projects from the bottom plate portion and the bottom plate portion Formed on an annular wall portion, a seal member peripheral portion pressing portion formed by an outer edge side portion of the upper surface of the annular wall portion, and an inner edge side portion of the upper surface of the annular wall portion, protruding upward and having an inner diameter upward.
- the ring-shaped upper member has an annular inclined surface that expands toward the diameter and can be inserted into the seal member, and the ring-shaped upper member protrudes from the center portion of the seal member.
- Storing the seal member A main body part, and an annular projecting part that protrudes inward from the opening of the main body part and presses the peripheral part of the seal member; and the seal member is formed on the main body part and the peripheral part of the main body part.
- the annular edge portion of the portion is inserted, and the sealing member is deformed by strong compression between the upper member and the bottom member and insertion of the annular edge portion of the bottom member, and the flange portion
- the height is reduced, the height of the insertion part in the bottom member is increased, the skirt-like protrusion is reduced, and the outer peripheral surface of the lower end of the insertion part in the bottom member is the annular shape of the bottom member.
- Subcutaneous implantable drug injector that is in close contact with the inner surface of the wall.
- FIG. 1 is a perspective view of a chemical liquid injector of the present invention.
- FIG. 2 is a plan view of the chemical liquid injector of the present invention.
- FIG. 3 is a front view of the chemical solution injector shown in FIG. 4 is a cross-sectional view taken along line AA in FIG. 5 is a cross-sectional view taken along the line BB in FIG.
- FIG. 6 is a front view of a seal member (septum) used in the chemical liquid injector of the present invention.
- FIG. 9 is a plan view of a bottom member used in the chemical liquid injector of the present invention.
- FIG. 10 is a cross-sectional view taken along the line DD of FIG.
- FIG. 11 is an explanatory diagram for explaining a state before the chemical liquid injector of the present invention is fixed.
- FIG. 12 is an external view of the drug solution injector of the present invention with a catheter attached.
- FIG. 13 is a plan view of a drug solution injector according to another embodiment of the present invention.
- 14 is a cross-sectional view taken along the line EE of FIG. 15 is a bottom view of the chemical liquid injector shown in FIG.
- the subcutaneously implantable drug solution injector of the present invention will be described with reference to the illustrated embodiment.
- the subcutaneous implantable drug solution injector 1 of the present invention is accommodated between an upper body 3 and a bottom member 2, an infusion tool body composed of a ring-shaped upper member 3 and a bottom member 2 that closes the bottom surface of the upper member 3,
- a seal member 4 that closes the opening of the upper member 3 and forms a chemical solution inflow space 10 in the injection tool main body, and a discharge port 5 that communicates with the chemical solution inflow space 10 are provided.
- the bottom member 2 includes a bottom plate portion 21, an annular wall portion 22 protruding from the bottom plate portion 21, a seal member peripheral portion pressing portion 22 a formed by an outer edge side portion of the upper surface of the annular wall portion 22, and the annular wall portion 22. And an annular edge portion 25 that has an annular inclined surface that protrudes upward, has an inner diameter that expands upward, and can be inserted into the seal member 4.
- the ring-shaped upper member 3 protrudes inward from the main body 31 that houses the seal member 4 in a state in which the central portion of the seal member 4 is exposed (protruded), and the opening of the main body 31, and the peripheral edge of the seal member 4
- An annular protrusion 32 is provided to press the portion.
- the sealing member 4 is formed on the peripheral portion of the main body 41 and the flange 41 for being pressed by the lower surface of the annular protrusion 32 of the upper member 3 and the upper surface of the annular wall 22 of the lower member.
- the bottom member internal insertion portion 41b is formed by a lower portion than the flange portion 42, and the skirt-shaped protrusion 43 is formed at the peripheral edge of the lower surface of the bottom member internal insertion portion 41b and becomes thinner toward the end portion.
- the seal member 4 has the upper surface side of the flange portion 42 pressed by the annular protrusion 32 of the upper member 3, and the outer edge portion of the lower surface side of the flange portion 42 is the seal member peripheral portion pressing portion on the upper surface of the annular wall portion 22 of the bottom member 2.
- the annular edge portion 25 of the annular wall portion 22 of the bottom member 2 is inserted into the inner edge portion on the lower surface side of the flange portion 42, and the seal member 4 includes the upper member 3 and the bottom member 2.
- the subcutaneous implantable drug injector 1 of this embodiment is composed of an injector main body and a seal member 4 as shown in FIGS. And the injection tool main body was attached to the bottom part 2 which has the recessed part which forms the chemical
- the seal member 4 is disposed between the bottom member 2 and the upper member 3, and the flange portion 42 is clamped by the bottom member 2 and the upper member 3, so that the bottom member 2 and the upper member 3 are liquid-tight. It is sealed.
- the ring-shaped upper member 3 includes a ring-shaped main body 31 that accommodates the seal member 4 in a state where the central portion of the seal member 4 is exposed, and an inner portion (center direction) of the opening from the upper opening of the main body 31. ) Projecting annular projection 32.
- the annular projecting portion 32 is for pressing the upper surface of the peripheral edge portion (flange portion) 42 of the seal member 4 at its lower surface.
- the annular protrusion 32 is formed on the inner edge side portion of the lower surface of the annular protrusion 32, protrudes downward, and has an annular inclined surface having an annular inclined surface whose inner diameter expands downward. 39 is provided.
- the annular edge portion 39 can be inserted into the upper surface of the flange portion of the seal member 4.
- the annular protrusion 32 has a seal member peripheral portion pressing portion 32 a formed on the outer side of the annular edge portion 39 and having an annular and flat surface.
- the seal member peripheral edge pressing portion 32 a presses (compresses) the flange portion 42 of the seal member 4.
- the upper member 3 includes side bulging portions 34 and 35 provided on both sides of the tip of the upper member 3 as shown in FIGS. 2, 3, and 5. Further, the discharge port 5 is located between the side bulging portions 34 and 35. Further, as shown in FIGS. 1 and 3 (particularly, FIG. 1), the upper member 3 is formed between the rear end portion 33 and the side bulging portions 34 and 35, and is substantially a standing surface, and the side portion. In the vicinity of the bulging portions 34 and 35, there are two standing upright side portions 37 and 38 for gripping that are greatly curved as compared with other portions. The center of the seal member 4 is located between the two gripping standing side surfaces 37 and 38 facing each other.
- the central portion of the seal member 4 is located between the portions that are largely curved in the vicinity of the side bulging portions 34 and 35 of the two opposing standing side surfaces 37 and 38 for gripping.
- the upper member 3 has a rear end portion 33 that extends to the opposite side of the discharge port 5 from the outer edge of the annular protrusion at a position facing the discharge port 5.
- the rear end portion 33 is thinner toward the rear end side, and the width is also narrower.
- the rear end 33 has a crescent shape that is slightly collapsed, as shown in FIG.
- the standing side surface portions 37 and 38 extend from the rear end portion 33 toward the side bulging portions 34 and 35, and the height of the standing side surface portion gradually increases. The height is higher, and the vicinity of the central side portion of the annular projecting portion 32 is the highest, and rapidly decreases toward the side bulging portions 34 and 35. As described above, since the gripping standing side surface portions 37 and 38 are the highest in the vicinity of the central side portion of the annular projecting portion 32, the central side portion of the annular projecting portion 32 can be easily gripped.
- the fingertip when grasping, feels a portion that is largely curved in the vicinity of the side bulging portions 34 and 35, so that the central portion of the annular protrusion 32 (in other words, the central portion of the seal member 4) is between the gripping portions. You can easily recognize that there is.
- Providing such standing side surfaces 37 and 38 for gripping facilitates the puncturing operation of the drug injection needle after being implanted subcutaneously, and facilitates handling in the subcutaneous implantation procedure.
- the upper member 3 includes standing side surface portions 37 and 38 and a cylindrical portion 36 formed between the upper ends of the upper member 3 and having a substantially cylindrical shape or a diameter that is slightly reduced toward the upper end direction.
- the cylindrical portion 36 is gradually reduced in diameter toward the upper side.
- the side bulging portions 34, 35 become thinner toward the ends of the side bulging portions 34, 35 and penetrate from the upper surface to the lower surface.
- a through-hole is provided, and elastic members 8 and 9 that can be pierced by a suture needle are embedded in the through-hole, and the side bulging portions 34 and 35 are sewn portions to a living body.
- the elastic members 8 and 9 are made of an elastic material. Examples of the material for forming the elastic member include various rubbers such as silicone rubber, isoprene rubber and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft vinyl chloride, or combinations of two or more thereof. Of these, silicone rubber is particularly preferable because it is inert to the living body and has relatively little change in physical properties.
- the bottom surface form of the upper member in this embodiment is a semi-elliptical shape in which both sides of the proximal end swell, and the upper surface is centered on the proximal end side of the bottom surface form. It has a round shape.
- the bottom member 2 includes a bottom plate portion 21, an annular wall portion 22 that protrudes from the bottom plate portion 21, and a rear end portion 23.
- the annular wall portion 22 is substantially cylindrical and includes a recess 26 for forming the chemical solution inflow space 10 therein. Further, the annular wall portion 22 includes a discharge port mounting portion 24 that communicates with the concave portion 26 at a lower portion of the side surface.
- the discharge port mounting portion 24 is a cylindrical portion that protrudes from the annular wall portion 22 of the bottom member 2, and includes a lumen portion into which the proximal end portion of the discharge port 5 can be inserted.
- the bottom plate portion 21 has a semi-elliptical shape in which both sides of the base end are cut off, and the annular wall portion is provided at a position whose center is based on the base end side of the bottom surface form. ing.
- the bottom member 2 has a seal member peripheral portion pressing portion 22 a formed by the outer edge side portion of the upper surface of the annular wall portion 22. Further, an annular edge formed on an inner edge side portion (in other words, inside the seal member peripheral edge pressing portion 22a) on the upper surface of the annular wall portion 22 and having an annular inclined surface that protrudes upward and whose inner diameter increases upward.
- the unit 25 is provided. The annular edge portion 25 can be inserted into the lower surface of the flange portion 42 of the seal member 4.
- the seal member 4 has a cylindrical main body 41 and an annular flange 42 formed on the peripheral edge of the main body 41 so as to protrude from the main body.
- the flange portion 42 is a portion to be pressed by the lower surface of the annular projecting portion 32 of the upper member 3 and the upper surface of the annular wall portion 22 of the lower member. Further, the seal member 4 of this embodiment is formed below the flange portion 42, has an outer diameter smaller than that of the flange portion, and a bottom member insertion portion 41b that is substantially equal to the inner diameter of the annular wall portion described above, and the flange portion.
- the upper member insertion portion 41a is formed above 42, has an outer diameter smaller than that of the flange portion, and is substantially equal to or slightly smaller than the inner diameter of the annular protrusion of the upper member 3 described above.
- the seal member 4 includes a skirt-like projecting portion 43 that is formed on the peripheral edge portion of the lower surface 44 of the bottom member inner insertion portion 41b and becomes thinner toward the end portion. As shown in FIG. 8, the skirt-like projecting portion 43 becomes thinner toward the lower end and the inner diameter is increased. For this reason, the inner surface of the skirt-like protrusion 43 is an inclined surface that increases in diameter toward the lower end (specifically, a curved inclined surface that increases in diameter toward the lower end).
- the upper member insert portion 41a of the seal member 4 is inserted into the opening of the upper member 3, and its upper end protrudes from the upper surface of the upper member 3 as shown in FIGS.
- the bottom member internal insertion portion 41b of the seal member 4 is accommodated and entered into the annular wall portion 22 of the bottom member 2 as shown in FIGS.
- medical solution inflow space 10 is formed by the lower surface 44 of the bottom part member insertion part 41b of the sealing member 4, and the inner surface of the recessed part 26 of the bottom member 2. As shown in FIG.
- the injection tool main body bottom member 2, upper member 3
- a material having chemical resistance and biocompatibility is preferable, and polysulfone, polyethersulfone, epoxy resin, polyacetal and the like are used.
- the seal member 4 can be pierced by a needle for injecting a chemical liquid, and the piercing portion is sealed after the needle for injecting a chemical liquid is removed.
- the seal member 4 is made of an elastic material.
- various rubbers such as silicone rubber, isoprene rubber and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft vinyl chloride, or a combination of two or more of these may be used.
- silicone rubber which is inert to the living body and has relatively little change in physical properties.
- the sealing member 4 is such that the upper surface side 42 a of the flange portion 42 is pressed by the annular protrusion 32 of the upper member 3, and the lower surface side of the flange portion 42.
- the outer edge portion of 42 b is pressed by the seal member peripheral portion pressing portion 22 a on the upper surface of the annular wall portion 22 of the bottom member 2, and the annular portion of the annular wall portion 22 of the bottom member 2 is connected to the inner edge portion on the lower surface side of the flange portion 42.
- Edge portion 25 is inserted.
- the outer edge portion on the upper surface side of the flange portion 42 is pressed by the seal member peripheral portion pressing portion 32a on the lower surface of the annular projecting portion 32 of the upper member 3, and the inner edge on the upper surface side of the flange portion 42.
- An annular edge 39 of the annular protrusion 32 of the upper member 3 is inserted into the part.
- the flange portion 42 of the seal member 4 has the annular edge portions 25 and 39 inserted into the upper surface and the lower surface, so that the seal member is surely secured. And is securely held in a liquid-tight state.
- FIG. 11 is an explanatory diagram for explaining a state before the upper member and the bottom member of the chemical liquid injector 1 of this embodiment are fixed. As shown in FIG.
- the sealing member 4 has a height of the flange portion 42 reduced by 20 to 45%, preferably 25 to 40%.
- the height of the inner insertion portion 41b is increased 1.5 to 3 times, the height of the upper member inner insertion portion 41a is increased 1.3 to 2 times, and the height at the center portion of the seal member ( Thickness) has increased 1.5 to 2.5 times.
- the penetration depth of the bottom member insertion portion 41b into the lower member is increased due to the decrease in the height of the flange portion 42 and the increase in the height of the bottom member insertion portion 41b.
- the penetration depth of the upper member insertion portion 41a into the opening of the upper member increases, As shown in FIGS. 4 and 5, it protrudes from the opening of the upper member 2.
- the skirt-like projecting portion 43 of the seal member 4 is reduced, and the outer peripheral surface of the lower end of the bottom member insertion portion 41 b is in close contact with the inner surface of the annular wall portion 22 of the bottom member 2. is doing.
- the seal member 4 is strongly compressed between the upper member 3 and the bottom member 2 (specifically, compression that reduces the height (thickness) of the flange portion by 20% or more).
- the skirt-like protrusion 43 of the seal member 4 has almost disappeared due to the deformation caused by the insertion of the annular edge portion 25 of the bottom member 2.
- the height (thickness) of the seal member decreases and the height (thickness) increases as a whole (central portion). And is expected to have disappeared.
- the increase in thickness due to the above-described strong compression is to press the side surface of the bottom member insertion portion 41b of the seal member 4 against the inner surface of the annular wall portion 22 of the bottom member 2, and the adhesion between the two becomes more reliable. I think. In addition, when the annular edge portion 25 of the bottom member 2 was inserted into the inner corner portion of the lower surface of the flange portion 42 of the seal member 4 without providing the skirt-like projecting portion 43, the vicinity of the inner corner portion was pulled outward.
- the chemical solution inflow space 10 has a predetermined height formed by the inner surface of the seal member 4 and the inner surface of the recess 26 (the inner surface of the annular wall portion 22 and the upper surface of the bottom plate portion 21). It is a cylindrical space having a thickness.
- the lower surface 44 of the bottom member insertion portion 41b is a rough surface, specifically, an uneven surface or a satin surface. The rough surface can be formed by embossing the bottom surface forming portion of the bottom member insertion portion in the mold for molding the seal member 4 by blasting or the like, or by laser processing the seal member. it can.
- the lower surface 44 of the bottom member insertion portion 41 b of the seal member 4 is coated with an antithrombotic substance 61.
- the lower surface 44 of the bottom member insertion portion 41b may be coated with the antithrombotic substance 61 without having the uneven surface or the matte surface as described above.
- the inner surface of the bottom member 2 that forms the chemical solution inflow space 10 is also coated with the antithrombotic substance 62.
- antithrombotic substances examples include heparin, polyalkylsulfone, ethyl cellulose, acrylic acid ester polymers, methacrylic acid ester polymers (for example, poly HEMA [polyhydroxyethyl methacrylate]), hydrophobic segments and hydrophilic segments.
- Block or graft copolymer having both for example, HEMA-styrene-HEMA block copolymer, HEMA-MMA [methyl methacrylate] block copolymer, HEMA-LMA [lauryl methacrylate] block copolymer) , A block copolymer of PVP [polyvinylpyrrolidone] -MMA, a block copolymer of HEMA-MMA / AA [acrylic acid], and a blend polymer obtained by mixing the block copolymer with a polymer having an amino group, and fluorine-containing Tree
- a synthetic polymer mainly composed of an alkoxyalkyl (meth) acrylate composed of an alkoxy group having 1 to 4 carbon atoms and an alkyl group having 1 to 4 carbon atoms can be used.
- a synthetic polymer as a main component, a block copolymer of HEMA-styrene-HEMA, a block copolymer of HEMA-MMA [methyl methacrylate], a block copolymer of HEMA-MMA / AA [acrylic acid] and the like are preferable.
- a synthetic polymer mainly composed of an alkoxyalkyl (meth) acrylate is one or two or more homopolymers or copolymers of the following alkoxyalkyl (meth) acrylates or the alkoxyalkyl (meth) acrylate and It is a copolymer with a monomer that can be copolymerized.
- Alkoxyalkyl (meth) acrylate includes both alkoxyalkyl acrylate and alkoxyalkyl methacrylate. Specifically, methoxymethyl acrylate, methoxyethyl acrylate, methoxypropyl acrylate, ethoxymethyl acrylate, ethoxyethyl acrylate, Ethoxypropyl acrylate, ethoxybutyl acrylate, propoxymethyl acrylate, butoxyethyl acrylate, methoxybutyl acrylate, methoxymethyl methacrylate, methoxyethyl methacrylate, ethoxymethyl methacrylate, ethoxyethyl methacrylate, propoxymethyl methacrylate, butoxyethyl methacrylate, etc. Of these, methoxyethyl acetate Relate is preferable.
- Monomers that can be copolymerized with alkoxyalkyl (meth) acrylates include, for example, methyl acrylate, ethyl acrylate, propyl acrylate, butyl acrylate, 2-ethylhexyl acrylate, methyl methacrylate, ethyl methacrylate, butyl methacrylate, hexyl acrylate Hexyl methacrylate, ethylene, propylene and the like.
- a copolymerizable monomer what does not have a hydroxyl group or a cationic group in a molecule
- numerator is preferable.
- the copolymer may be any of a random copolymer, a block copolymer, and a graft copolymer, and can be synthesized by a known method such as radical polymerization, ionic polymerization, or polymerization using a macromer.
- the proportion of monomers to be copolymerized is preferably 50% or less. If it exceeds 50%, the effect of the alkoxyalkyl (meth) acrylate tends to decrease.
- the weight average molecular weight of the alkoxyalkyl (meth) acrylate polymer thus obtained is 10,000 to 1,000,000, preferably 20,000 to 100,000.
- the hydrophilic resin is composed of a hydroxyl group, an amino group, a carboxyl group, an epoxy group, an isocyanate group, an epoxy group, a thiocyanate group, an acid chloride group, an aldehyde group, and It is preferable to have any one of carbon-carbon double bonds or to have a group that can be easily converted into these groups. It is particularly preferable to use a blend polymer obtained by mixing the hydrophilic resin with an amino group-containing polymer, and the amino group-containing polymer is preferably a polyamine, particularly PEI [polyethyneimine].
- Heparin fixation is performed by coating the above-mentioned hydrophilic resin on the site to be fixed, contacting the surface with an aqueous heparin solution, and then aldehydes such as glutaraldehyde, terephthalaldehyde, formaldehyde, diphenylmethane diisocyanate, Fix by covalent bonding to the above hydrophilic resin by contacting with a fixing agent such as diisocyanate, carbodiimide modified diphenylmethane diisocyanate, epichlorohydrin, 1,4-butanediol diglycidyl ether, polyethylene glycol diglycidyl ether, etc. Can do.
- aldehydes such as glutaraldehyde, terephthalaldehyde, formaldehyde, diphenylmethane diisocyanate
- Fix by covalent bonding to the above hydrophilic resin by contacting with a fixing agent such as diisocyanate
- a discharge port 5 is attached to the chemical solution injector 1 of this embodiment.
- the discharge port 5 is a cylindrical body, and includes a catheter proximal end mounting portion 53 provided on the distal end side, a bottom member mounting portion 52 provided on the proximal end side, and a flow passage 51 provided inside. I have.
- the proximal end opening 50 is the proximal end of the flow passage 51 and is located at the proximal end of the bottom member mounting portion 24.
- An annular protrusion for preventing the catheter from coming off is provided on the outer surface of the catheter proximal end mounting portion 53.
- the bottom member mounting portion 52 is inserted into the discharge port mounting portion 24 of the bottom member 2 and is liquid-tightly fixed.
- titanium, titanium alloy, stainless steel, or the like can be used, and titanium or titanium alloy is particularly preferable.
- the catheter 7 and the protector 6 as shown in FIG. 12 are connected to the drug solution injector 1 of the present invention at the time of use.
- the proximal end portion 71 of the catheter 7 is attached to the discharge port 5 so as to encapsulate the catheter proximal end attachment portion 53, and the protector 6 is attached to the proximal end portion of the catheter 7 attached to the catheter proximal end attachment portion 53. 71 is fitted and pressed to prevent the catheter from being detached.
- a catheter that can be inserted into the body specifically, blood vessels (veins or arteries), bile ducts, vasculature and other vessels, epidural, subarachnoid, abdominal cavity.
- the catheter 7 is a tube body having a distal end side opening and an internal lumen, and has the same outer diameter and the same inner diameter throughout the entire body.
- the outer diameter of the catheter is preferably 0.3 to 5 mm, and particularly preferably 0.9 to 2.8 mm.
- the inner diameter of the catheter is preferably 0.1 to 2.6 mm, particularly preferably 0.6 to 1.8 mm.
- the catheter 7 is flexible and preferably has some elasticity.
- catheter forming material examples include olefin-based elastomers (for example, polyethylene elastomers and polypropylene elastomers), polyesters such as polyethylene terephthalate, soft polyvinyl chloride, polyurethane and urethane-based elastomers, polyamides and amide-based elastomers (for example, polyamide elastomers). And a flexible polymer material such as a fluororesin elastomer, an ethylene-vinyl acetate copolymer, and silicone rubber.
- olefin-based elastomers for example, polyethylene elastomers and polypropylene elastomers
- polyesters such as polyethylene terephthalate, soft polyvinyl chloride, polyurethane and urethane-based elastomers, polyamides and amide-based elastomers (for example, polyamide elastomers).
- a flexible polymer material such as a fluor
- the drug injection device of the present invention may have an X-ray contrast function like the drug injection device 1a shown in FIGS.
- FIG. 13 is a plan view of a chemical liquid injector 1a according to another embodiment of the present invention.
- 14 is a cross-sectional view taken along the line EE of FIG. 15 is a bottom view of the chemical liquid injector shown in FIG.
- the subcutaneous implantable drug injector 1a of this embodiment is similar to the subcutaneous implantable drug injector 1 described above, and includes an injector main body comprising a ring-shaped upper member 3 and a bottom member 2 that closes the bottom surface of the upper member 3.
- a seal member 4 that is housed between the upper member 3 and the bottom member 2, closes the opening of the upper member 3, and forms the chemical solution inflow space 10 in the injection tool body, and a discharge that communicates with the chemical solution inflow space 10. Port 5.
- a ring-shaped contrast member 15 is provided in the injection tool main body, specifically, in a gap formed between the ring-shaped upper member 3 and the bottom member 2.
- the contrast member 15 has an X-ray contrast function.
- the ring-shaped upper member 3, the bottom member 2, the seal member 4 and the discharge port 5 are the same as described above.
- the contrast member 15 is a thin plate ring-shaped member having a defect on the discharge port 5 side. Specifically, as shown in FIGS. 13 to 15, the contrast member 15 has a substantially elliptical outer edge and a substantially perfect inner edge as shown in FIG. It has a part. The contrast member 15 surrounds the outer periphery of the lower portion of the annular wall portion 22 from which the bottom member 2 protrudes, and the seal member 4 is located above the central portion. Therefore, it is possible to confirm the seal member 4 (punctureable portion) by X-ray contrast.
- the flange portion 42 of the seal member 4 includes the lower surface of the annular protrusion 32 of the upper member 3 and the upper surface of the annular wall portion 22 of the bottom member 2 in the same manner as the chemical injector 1 described above. And the height is reduced by 20 to 45% (preferably, reduced by 20 to 40%). That is, the flange portion 42 is pinched (strongly compressed) between the upper member 3 and the bottom member 2.
- the chemical solution injector is of a so-called high pressure type that does not leak even when the chemical solution is injected to a certain high pressure. That is, the drug solution injector of this embodiment can be used as an automatic injection port for a contrast medium in contrast CT for performing contrast medium administration.
- the contrast member 15 is provided with the cutout part 15a which consists of the mark which can associate contrast CT which performs contrast agent administration.
- the cutout portion 15a is composed of the letter “C”.
- the cutout portion may be “CT”.
- the cutout portion 15a made of a mark that can be associated with such contrast CT is provided in the contrast member 15, so that a mark that can be associated with contrast CT can be recognized by X-ray contrast, and is embedded in the skin. It can be recognized that the chemical liquid injector that is used can be used as an automatic injection port for a contrast medium in contrast CT.
- the chemical liquid injector 1a of the present invention includes a rear end portion 33 that becomes thinner toward the rear end side.
- the contrast member 15 has a wide central portion on the rear side. For this reason, the position of the rear end part of the chemical liquid injector 1a, that is, the indwelling state of the chemical liquid injector 1a can be confirmed by X-ray contrast.
- the contrast member 15 of this embodiment gradually increases in width from both sides toward the rear center, and is widest at the center.
- the central portion on the wide rear side faces the missing portion (discharge port 5).
- the contrast member 15 is a thin plate ring-shaped member having a defect portion on the discharge port 5 side. It is merely housed in a gap formed between the ring-shaped upper member 3 and the bottom member 2, but is not limited to this, for example, embedded in the upper surface of the bottom member 2 It may be embedded in the lower surface of the bottom member or embedded in the bottom surface of the upper member.
- the contrast member 15 has an inversion recognition function. Specifically, the contrast member 15 includes the cutout portion 15a described above in the wide portion described above. Further, the cutout portion 15a is asymmetrical. As described above, the cutout portion 15a has a “C” shape in this embodiment. In a normal indwelling form in which the seal member 4 (punctureable portion) is located on the upper side, the letter “C” can be recognized in X-ray contrast, as shown in FIG. In the state where the contrast member 15 is inverted and the seal member 4 (punctureable portion) is located on the lower side, as shown in the rear view of FIG.
- a metal plate having a high X-ray contrast metal plating such as gold, platinum, tungsten, titanium, titanium alloy, stainless steel, gold, platinum, or the like, a contrast material (gold, platinum, tungsten)
- a resin plate to which a metal powder such as barium sulfate or contrast medium such as bismuth carbonate is added can be used.
- a metal plate made of gold, platinum, tungsten, titanium, or a titanium alloy, or a metal plate having gold or platinum plating is preferable.
- the subcutaneous implantable drug solution injector of the present invention is as follows. (1) An injection tool body composed of a ring-shaped upper member and a bottom member that closes the bottom surface of the upper member, and is housed between the upper member and the bottom member, closes the opening of the upper member, and A subcutaneously implantable drug solution injector comprising a seal member that forms a drug solution inflow space in the injection device main body, and a discharge port that communicates with the drug solution inflow space,
- the bottom member includes a bottom plate portion, an annular wall portion protruding from the bottom plate portion, a seal member peripheral portion pressing portion formed by an outer edge side portion of the upper surface of the annular wall portion, and an upper surface of the annular wall portion.
- the ring-shaped upper member protrudes inward from a main body portion that houses the seal member in a state in which a central portion of the seal member protrudes, and presses a peripheral edge portion of the seal member.
- the seal member is formed on a peripheral portion of the main body portion, the flange portion for being pressed by the lower surface of the annular projecting portion of the upper member and the upper surface of the annular wall portion of the bottom member, A bottom member insertion portion formed below the flange portion, and a skirt-like protrusion formed on the lower peripheral edge of the bottom member insertion portion and becoming thinner toward the end,
- the seal member is configured such that the upper surface side of the flange portion is pressed by the annular projecting portion of the upper member, and the outer edge portion on the lower surface side of the flange portion is the seal member peripheral portion pressing portion on the upper surface of the annular wall portion of the bottom member.
- the annular edge portion of the annular wall portion of the bottom member is inserted into the inner edge portion on the lower surface side of the flange portion, and the seal member is interposed between the upper member and the bottom member. Due to strong compression by the insertion and insertion of the annular edge portion of the bottom member, the height of the flange portion decreases, the height of the insertion portion in the bottom member increases, and the skirt-like protrusion And the bottom end member insertion portion has a lower end outer peripheral surface that is in close contact with the inner surface of the annular wall portion of the bottom member.
- the liquid injector of the present invention there is no gap between the inner surface of the bottom member that houses the lower part of the seal member (septum) and the lower peripheral edge of the seal member (septum), so that blood can enter the gap. It is possible to prevent the occurrence of thrombus and the like.
- the annular projecting portion of the upper member is formed on an inner edge side portion of the lower surface of the annular projecting portion, has an annular inclined surface projecting downward, and having an inner diameter expanding downward, and the seal
- the subcutaneously implantable drug solution injector according to (1) above which has an annular edge portion that can be inserted into the flange portion of the member, and a seal member peripheral edge pressing portion formed outside the annular edge portion.
- the seal member includes an upper member insertion portion formed above the flange portion, and the seal member further includes strong compression between the upper member and the bottom member, and the upper member.
- the subcutaneously implantable drug solution injector according to (2) which protrudes from the portion.
- the subcutaneous implantable drug solution injector according to any one of (1) to (8), wherein the subcutaneous implantable drug solution injector includes a contrast member disposed in the injector body. (10) The flange portion of the seal member is pressed by the lower surface of the annular projecting portion of the upper member and the upper surface of the annular wall portion of the bottom member, and the height is reduced by 20 to 45%.
- the contrast-imparting member is a subcutaneously implantable drug solution injector according to (9), wherein the contrast member includes a cutout portion formed of a mark reminiscent of contrast CT for administering a contrast agent.
- the contrast-imparting member is a ring-shaped member having a defect portion, and the width of the central portion on the rear side is wide.
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Abstract
Description
これら薬液注入具は、リング状上部部材と底部部材とからなる本体と、上部部材と下部部材間により周縁部が押圧された状態にて、本体内収納されたシール部材(セプタム)とを備える。そして、シール部材(セプタム)の下面と本体内面により、薬剤注入用の内部空間が形成され、本体には、この空間に連通する薬液流出用の流路が設けられている。そして、シール部材(セプタム)は、ゴム製の栓体であり、薬剤注入用針による複数回の穿刺が可能となっている。
リング状の上部部材と前記上部部材の底面を閉塞する底部部材とからなる注入具本体と、前記上部部材と前記底部部材間に収納され、前記上部部材の開口を閉塞し、かつ、前記注入具本体内に薬液流入空間を形成するシール部材と、前記薬液流入空間と連通する排出ポートとを備える皮下埋め込み型薬液注入具であって、前記底部部材は、底板部と、前記底板部より、突出する環状壁部と、前記環状壁部の上面の外縁側部分により形成されたシール部材周縁部押圧部と、前記環状壁部の上面の内縁側部分に形成され、上方に突出し、内径が上方に向かって拡径する環状傾斜面を有し、かつ前記シール部材内に刺入可能な環状エッジ部とを備え、前記リング状の上部部材は、前記シール部材の中央部が突出する状態にて前記シール部材を収納する本体部と、前記本体部の開口部より内部に突出し、前記シール部材の周縁部を押圧するため環状突出部とを備え、前記シール部材は、本体部と、前記本体部の周縁部に形成され、前記上部部材の前記環状突出部の下面と前記底部部材の環状壁部の上面により押圧されるためのフランジ部と、前記フランジ部より下部に形成された底部部材内挿入部と、前記底部部材内挿入部の下面周縁部に形成され、端部に向かって肉薄となるスカート状突出部とを備え、前記シール部材は、前記フランジ部の上面側が前記上部部材の環状突出部により押圧され、前記フランジ部の下面側の外縁部が前記底部部材の前記環状壁部の上面の前記シール部材周縁部押圧部により押圧されるとともに、前記フランジ部の下面側の内縁部に、前記底部部材の前記環状壁部の前記環状エッジ部が刺入しており、前記シール部材は、前記上部部材と前記底部部材間による強圧縮と、前記底部部材の前記環状エッジ部の刺入により変形し、前記フランジ部の高さが減少し、かつ前記底部部材内挿入部の高さが増加し、さらに、前記スカート状突出部が減少するとともに、前記底部部材内挿入部の下端外周面が、前記底部部材の前記環状壁部の内面に密着している皮下埋め込み型薬液注入具。
本発明の皮下埋め込み型薬液注入具1は、リング状の上部部材3と上部部材3の底面を閉塞する底部部材2とからなる注入具本体と、上部部材3と底部部材2間に収納され、上部部材3の開口を閉塞し、かつ、注入具本体内に薬液流入空間10を形成するシール部材4と、薬液流入空間10と連通する排出ポート5とを備える。
シール部材4は、本体部41と、本体部41の周縁部に形成され、上部部材3の環状突出部32の下面と下部部材の環状壁部22の上面により押圧されるためのフランジ部42と、フランジ部42より下部により形成された底部部材内挿入部41bと、底部部材内挿入部41bの下面周縁部に形成され、端部に向かって肉薄となるスカート状突出部43とを備える。
シール部材4は、フランジ部42の上面側が上部部材3の環状突出部32により押圧され、フランジ部42の下面側の外縁部が底部部材2の環状壁部22の上面のシール部材周縁部押圧部22aにより押圧されるとともに、フランジ部42の下面側の内縁部に、底部部材2の環状壁部22の環状エッジ部25が刺入しており、シール部材4は、上部部材3と底部部材2間による強圧縮と、底部部材2の環状エッジ部25の刺入により変形し、フランジ部42の高さが減少し、かつ底部部材内挿入部41bの高さが増加し、さらに、シール部材4のスカート状突出部43が減少するとともに、底部部材内挿入部41bの下端外周面が、底部部材2の環状壁部22の内面に密着している。
さらに、上部部材3は、排出ポート5と向かい合う位置に、言い換えれば、環状突出部の外縁より、排出ポート5と反対側に延びる後端部33を有している。後端部33は、後端側に向かって肉薄となるとともに、幅も狭くなっている。この実施例のものでは、後端部33は、図2に示すように、少しつぶれた三日月状のものとなっている。
さらに、図1ないし図3および図5に示すように、側部膨出部34,35は、側部膨出部34,35の端部に向かって肉薄となるとともに、上面から下面まで貫通する貫通孔を備え、貫通孔には、縫合針による刺通可能な弾性部材8,9が埋め込まれており、側部膨出部34,35は、生体への縫着部となっている。
弾性部材8,9は、弾性材料により形成されている。弾性部材の形成材料としては、シリコーンゴム、イソプレンゴム、天然ゴム等の各種ゴム類、ポリウレタン、ポリアミドエラストマー、ポリブタジエン、軟質塩化ビニル等の各種樹脂、またはこれらのうち2以上を組み合わせたもの等が挙げられるが、そのなかでも特に、生体に対し不活性で、比較的物性変化の少ないシリコーンゴムが好ましい。
底部部材2は、図3,図5、図9および図10に示すように、底板部21と、底板部21より、突出する環状壁部22と、後端部23を備える。環状壁部22は、ほぼ円筒状のものであり、内部に薬液流入空間10を形成するための凹部26を備えている。さらに、環状壁部22は、その側面下部に、凹部26と連通する排出ポート装着部24を備えている。排出ポート装着部24は、底部部材2の環状壁部22より突出する筒状部であり、排出ポート5の基端部が挿入可能な内腔部を備えている。底板部21は、図9に示すように、基端両側部が欠けた半楕円状のものとなっており、環状壁部は、その中心が底面形態の基端側によった位置に設けられている。
シール部材4は、円柱状の本体部41と、本体部41の周縁部に、本体部より突出するように形成された環状のフランジ部42を有する。フランジ部42は、上部部材3の環状突出部32の下面と下部部材の環状壁部22の上面により押圧されるための部位である。さらに、この実施例のシール部材4は、フランジ部42より下部に形成され、外径がフランジ部より小さく、かつ、上述した環状壁部の内径とほぼ等しい底部部材内挿入部41bと、フランジ部42より上部に形成され、外径がフランジ部より小さく、かつ、上述した上部部材3の環状突出部の内径とほぼ等しいもしくは若干小さい上部部材内挿入部41aを備える。
そして、シール部材4の上部部材内挿入部41aは、上部部材3の開口部内に挿入され、その上端部は、図1ないし図5に示すように、上部部材3の上面より突出している。また、シール部材4の底部部材内挿入部41bは、図4および図5に示すように、底部部材2の環状壁部22内に収納され、進入している。そして、シール部材4の底部部材内挿入部41bの下面44と底部部材2の凹部26の内面間により、薬液流入空間10が形成されている。
シール部材4は、薬液注入用針の刺通が可能であり、薬液注入用針の抜去後に刺通部がシールされるものとなっている。シール部材4は、弾性材料により形成されている。シール部材4の形成材料としては、シリコーンゴム、イソプレンゴム、天然ゴム等の各種ゴム類、ポリウレタン、ポリアミドエラストマー、ポリブタジエン、軟質塩化ビニル等の各種樹脂、またはこれらのうち2以上を組み合わせたもの等が挙げられるが、そのなかでも特に、生体に対し不活性で、比較的物性変化の少ないシリコーンゴムが好ましい。
さらに、この実施例のものでは、フランジ部42の上面側の外縁部は、上部部材3の環状突出部32の下面のシール部材周縁部押圧部32aにより押圧され、フランジ部42の上面側の内縁部に、上部部材3の環状突出部32の環状エッジ部39が刺入したものとなっている。
上述したように、この実施例の薬液注入具1では、シール部材4のフランジ部42には、上面および下面に環状エッジ部25,39が刺入したものとなっているので、シール部材が確実に把持され、かつ液密状態を確実に保持するものとなっている。
そして、シール部材4は、上部部材3と底部部材2間による強圧縮(具体的には、底部部材2のシール部材周縁部押圧部22aと上部部材3のシール部材周縁部押圧部32aによる押圧による強圧縮)と、底部部材2の環状エッジ部25の刺入により、図6ないし図8および図11の状態から、図4および図5に示す形態に変形している。図11は、この実施例の薬液注入具1の上部部材と底部部材を固定する前の状態を説明するための説明図である。図11に示すように、底部部材2上にシール部材4を載せ、シール部材4の上に上部部材を被せた状態では、上部部材3の下面と底部部材2の上面間は、所定距離離間し、上部部材3が浮いた状態となっている。そして、上部部材3と下部部材2間により圧縮されることにより、シール部材4は、図11の状態から、図4および図5に示す形態に変形し、上部部材3と底部部材2は、当接し、その状態にて固着されている。
図11の状態から、図4および図5に示す形態に変形することにより、シール部材4は、フランジ部42の高さが、20~45%、好ましくは、25~40%減少し、底部部材内挿入部41bの高さが、1.5~3倍に増加し、上部部材内挿入部41aの高さが、1.3~2倍に増加し、シール部材の中央部での高さ(厚さ)が、1.5~2.5倍に増加している。
そして、フランジ部42の高さの減少と、底部部材内挿入部41bの高さの増加により、底部部材内挿入部41bの下部部材内への侵入深さは増加している。同様に、フランジ部42の高さの減少と、上部部材内挿入部41aの高さの増加により、上部部材内挿入部41aの上部部材の開口部内への侵入深さは増加し、その上部は、図4および図5に示すように、上部部材2の開口部より突出するものとなっている。さらに、図4および図5に示すように、シール部材4のスカート状突出部43が減少するとともに、底部部材内挿入部41bの下端外周面が、底部部材2の環状壁部22の内面に密着している。
また、上記の強圧縮による厚さの増加は、シール部材4の底部部材挿入部41bの側面を底部部材2の環状壁部22の内面に押しつけるものとなり、両者間の密着がより確実になるものと考える。
なお、スカート状突出部43を設けることなく、シール部材4のフランジ部42の下面の内側角部に、底部部材2の環状エッジ部25が刺入すると、内側角部付近が外側に引っ張られた状態となり、この引っ張りにより、シール部材4の底部部材内挿入部41bの側面部が引き上げられ、底部部材内挿入部41bの側面部の下端と底部部材2の環状壁部22の内面間に空隙が形成される可能性が高いものとなる。
また、この実施例の薬液注入具1では、シール部材4の上記変形に起因するものと考えるが、シール部材4の底部部材内挿入部41bの下面は、中央部が、若干窪んだ状態となっている。このようにシール部材4の底部部材内挿入部41bの下面の中央部が窪むことにより、薬液流入空間10の中央部分が高くなっている。
さらに、この実施例のシール部材4では、底部部材内挿入部41bの下面44は、粗面、具体的には、凹凸表面もしくは梨地状表面となっている。粗面は、シール部材4を成型する金型における底部部材内挿入部の下面形成部をブラスト処理などによるエンボス加工を行うことにより、また、シール部材をレーザー加工することなどにより、形成することができる。
さらに、この実施例では、シール部材4の底部部材内挿入部41bの下面44には、抗血栓性物質61が被覆されている。なお、底部部材内挿入部41bの下面44は、上記のような凹凸表面もしくは梨地状表面とすることなく、抗血栓性物質61を被覆してもよい。しかし、凹凸表面もしくは梨地状表面とした後、抗血栓性物質61を被覆することが好ましい。このようにすることにより、抗血栓性物質の被覆が確実になるととともに離脱も少ないものとなる。また、底部部材2の薬液流入空間10を形成する内面にも、抗血栓性物質62が被覆されていることが好ましい。
アルコキシアルキル(メタ)アクリレートを主成分としてなる合成高分子は、下記のアルコキシアルキル(メタ)アクリレートの1種または2種以上の単独重合体または共重合体あるいは該アルコキシアルキル(メタ)アクリレートとこれと共重合し得る単量体との共重合体である。
また、共重合性単量体としては、分子内にヒドロキシル基やカチオン性基を有しないものが好ましい。共重合体は、ランダム共重合体、ブロック共重合体、グラフト共重合体のいずれでもよく、ラジカル重合やイオン重合、マクロマーを利用した重合等の公知の方法により合成することができる。
いずれの共重合体の場合も、共重合する単量体の比率は50%以下であることが好ましい。50%を越えるとアルコキシアルキル(メタ)アクリレートによる効果が低下しやすい。このようにして得られるアルコキシアルキル(メタ)アクリレート重合体の重量平均分子量は10,000から1,000,000、好ましくは20,000から100,000が好ましい。
そして、カテーテル基端部装着部53の外面には、カテーテル抜け止め用の環状突出部が設けられている。底部部材装着部52は、底部部材2の排出ポート装着部24内に挿入され、液密に固定されている。
排出ポート5の形成部材としては、チタン、チタン合金、ステンレス鋼などが使用でき、特に、チタン、チタン合金が好ましい。
また、カテーテル7は、可撓性、好ましくはある程度の弾性を有するものが用いられる。カテーテルの形成材料としては、例えば、オレフィン系エラストマー(例えば、ポリエチレンエラストマー、ポリプロピレンエラストマー)、ポリエチレンテレフタレートなどのポリエステル、軟質ポリ塩化ビニル、ポリウレタンおよびウレタン系エラストマー、ポリアミドおよびアミド系エラストマー(例えば、ポリアミドエラストマー)、フッ素樹脂エラストマー、エチレン-酢酸ビニル共重合体、シリコーンゴム等の可撓性を有する高分子材料により形成される。
図13は、本発明の他の実施例の薬液注入具1aの平面図である。図14は、図13のE-E線断面図である。図15は、図13に示した薬液注入具の底面図である。
この実施例の皮下埋め込み型薬液注入具1aは、上述した皮下埋め込み型薬液注入具1と同様に、リング状の上部部材3と上部部材3の底面を閉塞する底部部材2とからなる注入具本体と、上部部材3と底部部材2間に収納され、上部部材3の開口を閉塞し、かつ、注入具本体内に薬液流入空間10を形成するシール部材4と、薬液流入空間10と連通する排出ポート5とを備える。そして、注入具本体内、具体的には、リング状の上部部材3と底部部材2間に形成された間隙部に収納されたリング状の造影性部材15を備えている。この造影性部材15により、X線造影機能を備えるものとなっている。リング状の上部部材3、底部部材2、シール部材4および排出ポート5は、上述したものと同じである。
(1) リング状の上部部材と前記上部部材の底面を閉塞する底部部材とからなる注入具本体と、前記上部部材と前記底部部材間に収納され、前記上部部材の開口を閉塞し、かつ、前記注入具本体内に薬液流入空間を形成するシール部材と、前記薬液流入空間と連通する排出ポートとを備える皮下埋め込み型薬液注入具であって、
前記底部部材は、底板部と、前記底板部より、突出する環状壁部と、前記環状壁部の上面の外縁側部分により形成されたシール部材周縁部押圧部と、前記環状壁部の上面の内縁側部分に形成され、上方に突出し、内径が上方に向かって拡径する環状傾斜面を有し、かつ前記シール部材内に刺入可能な環状エッジ部とを備え、
前記リング状の上部部材は、前記シール部材の中央部が突出する状態にて前記シール部材を収納する本体部と、前記本体部の開口部より内部に突出し、前記シール部材の周縁部を押圧するため環状突出部とを備え、
前記シール部材は、本体部と、前記本体部の周縁部に形成され、前記上部部材の前記環状突出部の下面と前記底部部材の環状壁部の上面により押圧されるためのフランジ部と、前記フランジ部より下部に形成された底部部材内挿入部と、前記底部部材内挿入部の下面周縁部に形成され、端部に向かって肉薄となるスカート状突出部とを備え、
前記シール部材は、前記フランジ部の上面側が前記上部部材の環状突出部により押圧され、前記フランジ部の下面側の外縁部が前記底部部材の前記環状壁部の上面の前記シール部材周縁部押圧部により押圧されるとともに、前記フランジ部の下面側の内縁部に、前記底部部材の前記環状壁部の前記環状エッジ部が刺入しており、前記シール部材は、前記上部部材と前記底部部材間による強圧縮と、前記底部部材の前記環状エッジ部の刺入により変形し、前記フランジ部の高さが減少し、かつ前記底部部材内挿入部の高さが増加し、さらに、前記スカート状突出部が減少するとともに、前記底部部材内挿入部の下端外周面が、前記底部部材の前記環状壁部の内面に密着している皮下埋め込み型薬液注入具。
このため、本発明の薬液注入具では、シール部材(セプタム)の下部を収納する底部部材の内面とシール部材(セプタム)の下面周縁部間に、空隙を持たず、空隙への血液の侵入に起因する血栓等の発生を防止することができる。
(2) 前記上部部材の前記環状突出部は、前記環状突出部の下面の内縁側部分に形成され、下方に突出し、内径が下方に向かって拡径する環状傾斜面を有し、かつ前記シール部材のフランジ部に刺入可能な環状エッジ部と、前記環状エッジ部の外側に形成されたシール部材周縁部押圧部とを有している上記(1)に記載の皮下埋め込み型薬液注入具。
(3) 前記シール部材は、前記フランジ部より上部に形成された上部部材内挿入部を備え、さらに、前記シール部材は、前記上部部材と前記底部部材間による強圧縮と、前記上部部材の前記環状エッジ部の刺入により変形し、前記フランジ部の高さが減少し、かつ前記上部部材内挿入部の高さが増加し、かつ、前記上部部材内挿入部は、前記上部部材の前記開口部より突出している上記(2)に記載の皮下埋め込み型薬液注入具。
(4) 前記シール部材の前記底部部材内挿入部の下面は、粗面となっている上記(1)ないし(3)のいずれかに記載の皮下埋め込み型薬液注入具。
(5) 前記シール部材の前記底部部材内挿入部の下面には、抗血栓性物質が被覆されている上記(1)ないし(4)のいずれかに記載の皮下埋め込み型薬液注入具。
(6) 前記底部部材の前記薬液流入空間を形成する内面には、抗血栓性物質が被覆されている上記(1)ないし(5)のいずれかに記載の皮下埋め込み型薬液注入具。
(7) 前記シール部材は、前記上部部材と前記底部部材間による押圧と、前記底部部材の前記環状エッジ部の刺入により変形し、前記シール部材の前記スカート状突出部がほぼ消失した状態となっている上記(1)ないし(6)のいずれかに記載の皮下埋め込み型薬液注入具。
(8) 前記底部部材の前記環状壁部には、前記排出ポートの基端部が挿入される排出ポート装着部を備えている上記(1)ないし(7)のいずれかに記載の皮下埋め込み型薬液注入具。
(10) 前記シール部材の前記フランジ部は、前記上部部材の前記環状突出部の下面と前記底部部材の環状壁部の上面により押圧され、高さが、20~45%減少しているものであり、前記造影性部材は、造影剤投与を行う造影CTを連想可能なマークからなる切り抜き部を備えている上記(9)に記載の皮下埋め込み型薬液注入具。
(11) 前記造影性部材は、欠損部を有するリング状部材であり、かつ、後部側の中央部の幅が広いものとなっている上記(9)または(10)に記載の皮下埋め込み型薬液注入具。
(12) 前記切り抜き部は、左右非対称である上記(10)に記載の皮下埋め込み型薬液注入具。
Claims (12)
- リング状の上部部材と前記上部部材の底面を閉塞する底部部材とからなる注入具本体と、前記上部部材と前記底部部材間に収納され、前記上部部材の開口を閉塞し、かつ、前記注入具本体内に薬液流入空間を形成するシール部材と、前記薬液流入空間と連通する排出ポートとを備える皮下埋め込み型薬液注入具であって、
前記底部部材は、底板部と、前記底板部より、突出する環状壁部と、前記環状壁部の上面の外縁側部分により形成されたシール部材周縁部押圧部と、前記環状壁部の上面の内縁側部分に形成され、上方に突出し、内径が上方に向かって拡径する環状傾斜面を有し、かつ前記シール部材内に刺入可能な環状エッジ部とを備え、
前記リング状の上部部材は、前記シール部材の中央部が突出する状態にて前記シール部材を収納する本体部と、前記本体部の開口部より内部に突出し、前記シール部材の周縁部を押圧するため環状突出部とを備え、
前記シール部材は、本体部と、前記本体部の周縁部に形成され、前記上部部材の前記環状突出部の下面と前記底部部材の環状壁部の上面により押圧されるためのフランジ部と、前記フランジ部より下部に形成された底部部材内挿入部と、前記底部部材内挿入部の下面周縁部に形成され、端部に向かって肉薄となるスカート状突出部とを備え、
前記シール部材は、前記フランジ部の上面側が前記上部部材の環状突出部により押圧され、前記フランジ部の下面側の外縁部が前記底部部材の前記環状壁部の上面の前記シール部材周縁部押圧部により押圧されるとともに、前記フランジ部の下面側の内縁部に、前記底部部材の前記環状壁部の前記環状エッジ部が刺入しており、前記シール部材は、前記上部部材と前記底部部材間による強圧縮と、前記底部部材の前記環状エッジ部の刺入により変形し、前記フランジ部の高さが減少し、かつ前記底部部材内挿入部の高さが増加し、さらに、前記スカート状突出部が減少するとともに、前記底部部材内挿入部の下端外周面が、前記底部部材の前記環状壁部の内面に密着していることを特徴とする皮下埋め込み型薬液注入具。 - 前記上部部材の前記環状突出部は、前記環状突出部の下面の内縁側部分に形成され、下方に突出し、内径が下方に向かって拡径する環状傾斜面を有し、かつ前記シール部材のフランジ部に刺入可能な環状エッジ部と、前記環状エッジ部の外側に形成されたシール部材周縁部押圧部とを有している請求項1に記載の皮下埋め込み型薬液注入具。
- 前記シール部材は、前記フランジ部より上部に形成された上部部材内挿入部を備え、さらに、前記シール部材は、前記上部部材と前記底部部材間による強圧縮と、前記上部部材の前記環状エッジ部の刺入により変形し、前記フランジ部の高さが減少し、かつ前記上部部材内挿入部の高さが増加し、かつ、前記上部部材内挿入部は、前記上部部材の前記開口部より突出している請求項2に記載の皮下埋め込み型薬液注入具。
- 前記シール部材の前記底部部材内挿入部の下面は、粗面となっている請求項1ないし3のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記シール部材の前記底部部材内挿入部の下面には、抗血栓性物質が被覆されている請求項1ないし4のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記底部部材の前記薬液流入空間を形成する内面には、抗血栓性物質が被覆されている請求項1ないし5のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記シール部材は、前記上部部材と前記底部部材間による押圧と、前記底部部材の前記環状エッジ部の刺入により変形し、前記シール部材の前記スカート状突出部がほぼ消失した状態となっている請求項1ないし6のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記底部部材の前記環状壁部には、前記排出ポートの基端部が挿入される排出ポート装着部を備えている請求項1ないし7のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記皮下埋め込み型薬液注入具は、前記注入具本体内に配置された造影性部材を備える請求項1ないし8のいずれかに記載の皮下埋め込み型薬液注入具。
- 前記シール部材の前記フランジ部は、前記上部部材の前記環状突出部の下面と前記底部部材の環状壁部の上面により押圧され、高さが、20~45%減少しているものであり、前記造影性部材は、造影剤投与を行う造影CTを連想可能なマークからなる切り抜き部を備えている請求項9に記載の皮下埋め込み型薬液注入具。
- 前記造影性部材は、欠損部を有するリング状部材であり、かつ、後部側の中央部の幅が広いものとなっている請求項9または10に記載の皮下埋め込み型薬液注入具。
- 前記切り抜き部は、左右非対称である請求項10に記載の皮下埋め込み型薬液注入具。
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JP2013550308A JP6057916B2 (ja) | 2011-12-21 | 2012-12-19 | 皮下埋め込み型薬液注入具 |
US14/367,646 US20150343192A1 (en) | 2011-12-21 | 2012-12-19 | Liquid medicine injection device of subcutaneous implant type |
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EP2796163A4 (en) | 2015-05-20 |
JPWO2013094644A1 (ja) | 2015-04-27 |
US20150343192A1 (en) | 2015-12-03 |
EP2796163A1 (en) | 2014-10-29 |
JP6057916B2 (ja) | 2017-01-11 |
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